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The device is intended to cover an ultrasound transducer and to act as a microbial barrier between the patient and the transducer during transvaginal procedures within assisted reproductive technology or gynecology, for clinical and hospital use by healthcare professionals in adult patients undergoing these procedures.

The Ultrasound Transducer Cover is an elastic cover made of thermoplastic polyurethane (TPU), which is placed over the ultrasound transducer during ultrasound quided procedures within assisted reproductive technology or gynecology. The Ultrasound Transducer Cover is provided sterile (ethylene oxide), for single use, and used with an ultrasound transducer probe to facilitate ultrasound scans. The Ultrasound Transducer Cover is available in various sizes with different widths of the cover. This is to allow for use with various sizes of ultrasound transducer probe.

Ultra RapidWarm™ Blast is indicated for warming of vitrified human blastocyst stage embryos.

Ultra RapidWarm Blast is intended for warming vitrified human blastocyst stage embryos. The device consists of a single solution composed of a MOPS buffered solution containing gentamicin, human serum albumin (HSA) and sucrose. The medium is aseptically filtered into gamma sterilized 5 mL PETG bottles with HDPE closures and a tamper evident seal. The medium can be used for up to 14 days after bottle opening.

Gx-IVF™ medium is intended for preparation and handling of gametes, for in vitro fertilisation and intrauterine insemination. Gx-TL™ medium is intended for culture of embryos from fertilisation to the blastocyst stage and for embryo transfer. Gx-MOPS™ PLUS medium is intended for handling and manipulating oocytes and embryos in ambient atmosphere.

The subject devices are culture and handling media consisting of physiological salts, energy substrates, amino acids, buffering agents, nutrients supplements, antioxidants, gentamicin and human serum albumin. These devices have different applications in Assisted Reproduction Technology (ART) procedures handled by IVF professionals. The media are aseptically filtered into gamma sterilised PETG bottles with HDPE closure and a tamper evident seal and tested for pH, osmolality, embryo toxicity, endotoxins, and sterility.

RapidVit™ Oocyte: Media for vitrification of human oocytes (MII). RapidWarm™ Oocyte: Media for warming of vitrified human oocytes (MII).

Two sets of media are covered by this 510(k), the RapidVit™ Oocyte for vitrification of oocytes and the RapidWarm™ Oocyte for warming of vitrified oocytes. RapidVit™ Oocyte contains three medium solutions to be used sequentially during oocyte vitrification. RapidWarm™ Oocyte includes four medium solutions to be used sequentially during oocyte warming.

Cryopreservation device intended to be used to contain, vitrify and maintain human embryos and/or oocytes (MI).

Rapid-i™ Kit is a modified version of the predicate device (K140207). This device is a cryopreservation storage device intended for embryo/oocyte vitrification. Rapid-i™ Kit is provided sterile and is for single-use only. This device consists of the following items: - Rapid-i Stick – A 80 mm long Polymethyl methacrylate (PMMA) stick with a 0.4 mm diameter hole located near the distal tip of the device. The hole on the stick is used to hold one to five embryos or oocytes for vitrification in a 30 nL drop of vitrification medium. Users suspend samples across the hole via surface tension. Therefore, the medium containing the samples only touches the periphery of the hole. The stick has one flat side that aids in correct orientation of the device during oocyte/embryo loading procedures. - RapidStraw A 130 mm long Mediprene straw equipped with a stainless steel weight to maintain device orientation in liquid nitrogen (LN). The straw has a flared open end to allow for insertion of the Rapid-i Stick. This component functions as a protective sleeve around the Rapid-i Stick to prevent direct contact with LN during loading and after sealing the open end with an ultrasonic sealing device. - Stainless steel rod - This 115 mm long stainless steel rod resides within RapidStraw during pre-cooling procedures in LN. It aids in keeping RapidStraw straight in LN during pre-cooling. Rod removal occurs 20-30 seconds prior to Rapid-i Stick loading into the RapidStraw.

Intended for flushing and/or aspiration of oocytes from ovarian follicles.

The Follicle Aspiration Set. Reduced Single Lumen proposed in this submission is intended for ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles. This product is comprised of the following components: - A stainless steel needle . - A silicone cork to be pushed into the opening of a sampling tube . - A length of TPE-O tubing for aspiration and flushing ● - An adapter for flushing . The subject device is provided sterile and is for single use only. It comes in four versions with the same design but different dimensions, as described below.

Intended for flushing and/or aspiration of oocytes from ovarian follicles

Follicle Aspiration Sets included in this submission are intended for ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles. Four types of Follicle Aspiration Sets are included in this submission, and are described in more detail below. The Follicle Aspiration Sets are radiation sterilized and are for single use only. The materials used in these devices include: stainless steel, TPE-O tubing, silicone, medical grade adhesive, polypropylene, and methyl methacrylate acrylonitrile butadiene styrene. Follicle Aspiration Set, Single Lumen: This device consists of a single-lumen stainless steel needle, aspiration tubing, and a silicone rubber cork for attachment to a collection tube. One version (17132) also includes vacuum tubing attached to the silicone rubber cork for attachment to the vacuum pump used for aspiration. This device also includes an adapter for flushing of ovarian follicles and removal of blockages. The needles for the majority of the versions of this device type include echogenic markings at the tip of the needle to aid in visualization during aspiration procedures. Follicle Aspiration Set, Double Lumen: This device consists of a double lumen stainless steel needle, tubing for flushing of ovarian follicles and removal of blockages, tubing for aspiration, and a silicone rubber cork for attachment to a collection tube. One version (17129) also includes vacuum tubing attached to the silicone rubber cork for attachment to the vacuum pump used for aspiration. The needles for these versions of the device include echogenic markings at the tip of the needle to aid in visualization during aspiration procedures. Follicle Aspiration Set, Single Lumen Luer with Tubing: This device consists of a single lumen stainless steel needle, and aspiration tubing with a luer connection at the end. The needle is provided with echogenic markings at the tip of the needle to aid in visualization during aspiration procedures. Follicle Aspiration Set, Single Lumen, Luer: This device consists of a single lumen stainless steel needle with a luer connection at the base of the needle. The needle is provided with echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.

FreezeKit™ Cleave is intended for freezing of pronuclear (2PN) and cleavage-stage embryos. ThawKit™ Cleave is intended for thawing of frozen pronuclear (2PN) and cleavage-stage embryos.

FreezeKit™ Cleave and ThawKit™ Cleave are devices used for freezing of pronuclear (2PN) and cleavage-stage embryos, and thawing of frozen pronuclear (2PN) and cleavage-stage embryos during in vitro fertilization (IVF) procedures. The proposed devices are two separate kits, containing two and three solutions respectively. The two kits are marketed separately, yet are recommended to be used together to perform freezing and thawing. All solutions in both kits contain MOPS buffered solution, gentamicin as an antibacterial agent, human serum albumin and hyaluronan. The cryoprotectants 1,2 - propanediol and sucrose are included in the freezing solution, and only sucrose is included as a cryoprotectant in the thawing solutions.

The Rapid-i™ Kit is a cryopreservation device designed to contain 4-8 cell and blastocyst stage human embryos.

Rapid-iTM Kit, a cryopreservation device designed to contain, vitrify and maintain 4-8 cell and blastocyst stage human embryos, consists of the following three items: • 80 mm PMMA stick (Rapid-iTM) • 135 mm Mediprene straw equipped with a stainless steel weight, (RapidStraw) • 115 mm stainless steel rod inserted in the RapidStraw